Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3

Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China.

The trial enrolled 145 patients who received one of three dose levels of CUE-221 or placebo subcutaneously every four weeks. At week 12, complete resolution of hives was observed in 43% to 54% of the CUE-221 groups, compared with 11% on placebo, and all differences were statistically significant.

A comparative arm using Xolair showed a 41% resolution rate, numerically lower than CUE-221, though the study was not powered for statistical comparison. A secondary endpoint using the UAS7 scale also favored CUE-221, with 38% to 46% of patients achieving a complete response.

Buoyed by these results, Cue plans to move CUE-221 into a combined phase 2b/3 trial. The company had previously acquired ex‑China rights to the asset for $15 million in April.